FDA Warning Letter to Healthy Habits

March 28, 2019

 

   

 
 
Los Angeles District

19701 Fairchild Road

Los Angeles, CA 92612 

 

WARNING
LETTER
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
December 16, 2016
WL # 10-17
Matthew Martin, President & CEO
Healthy Habits, LLC
15610 N. 83
rd Way
Scottsdale, AZ 85260
 
Dear Mr. Martin:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://healthyhabits.com/ in October 2016 and has determined that you take orders there for the products Dermatox Ointment 1.7 oz and DermaTox® – 4 oz. The claims on your website establish that the products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.  You can find the Act and FDA regulations through links on FDA’s home pae at www.fda.gov.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Dermatox Ointment 1.7 oz and DermaTox® – 4 oz
 
Product Description
  • “DermaTox® is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…” 
Dermatox Ointment 1.7 oz Testimonials
  • “I use DermaTox® Ointment on these red patches that I get on my skin. It also helps me with my Diabetes related skin conditions…”
  • “I had ankle surgery not to (sic)long ago, the overall pain from the incision and the surgical repair it self (sic)was really making it difficult for me to do anything I tried your product and I was blown away! I cant (sic) believe it really works! The pain and swelling around the scar is going away! even see the scar shrinking a bit!…”
  • “I put some DermaTox® ointment on a mole on my wife’s back and the mole was g one (sic) in a month. I also use it on my toes due to my neuropathy…”
  • “I have horrible eczema all along the back of my neck and ears. Nothing ever seemed to work, it was painful and embarrassing! I tried your DermaTox Ointment® a few months ago with little to no expectations. I am glad I found you!…”
  • “I’m very pleased with the DermaTox® Ointment. I have diabetic sores on my legs and my feet because of poor circulation. I started using the DermaTox® Ointment on them and it is working great!…” 
Q&A
  • “2. I received my first order of DermaTox® and started using it. My purpose for using it was to remove the many skin tags that I have. I applied DermaTox® on my skin tags every 4-5 hours during the day for 1 week. I have continued to use it twice a day since then. I have not seen ANY change in my skin tags. I was under the impression that they would just fall off after a couple of days of using DermaTox®. What am I doing wrong? What do I need to do to get rid of them? A:…On the same day we may get a product review from someone raving about how well DermaTox® helped get rid of their skin tags and we may also receive a message saying that it did nothing…One thing that you can try is to continually soak the tag, if possible for your lifestyle, by using cotton soaked in DermaTox® held in place with a band-aid…This has worked for others as well as to heal infected cysts. Nothing on the planet helps to regenerate new cells like DermaTox®…”
  • “15: How can I explain to someone else what is in DermaTox® that cures so many skin problems? A:…The more you use DermaTox®, the more amazed you will be at how many uses it has for pain, wounds, cuts, bruises, sores, inflammation, blisters, abrasions and more…”
  • “32. I have been using DermaTox® Ointment on cuts and on an arm issue after a skin infection healed? A: Good. Nothing works as well to stimulate the growth of new cells like DermaTox®…”
  • “35. Can or should DermaTox® be used where pre‐cancers or even basal cell cancers exist on the skin? Would DermaTox® be helpful in repairing massively dosed skin by radiation 15 years ago (18,000 rads) for squamous cell carcinoma head & neck cancer? A: As we are not medical doctors, we cannot address direct medical questions. DermaTox is a natural skin wellness formula that has been used effectively by people with a wide variety of skin problems including skin cancer…” 
DermaTox® – 4 oz Testimonials
  • “My 3 year old granddaughter got severe shingles on her ear and side of face. Her doctors were stumped. I repeatedly sprayed DermaTox on it and within 24 hours there was a dramatic decrease and within a week it was gone! I also got a severe burn on the inside of my arm which blistered and became infected. I scar easily and assumed I was going to have one. Again I repeatedly sprayed DermaTox on it. No scar and not one mark where it was!  Key is the repeated spraying. It is great fro (sic) sunburns or any kind of burn, I am never without it!…”
  • “I ordered DermaTox® because I had a diabetic rash on my bottom. The Doctor prescribed all kinds of antibiotics and nothing worked. Ive (sic) been using DermaTox for several weeks and its almost cleared up!…”
  • “MY grand daughter had a horrible staff infection on her face. Thanks to the DermaTox® product that is now a thing of the past…”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
Please send your written response to this letter to:
 
Kelly Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
  
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions about the contents of this letter, please contact Daniel W. Cline, Compliance Officer, at 949-608-4433 or [email protected].
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Director, Los Angeles District
 
 
Cc:
Matthew Martin, President & CEO
Healthy Habits, LLC
P.O. Box 12069
Scottsdale, AZ 85267-2069

This page was posted on March 28, 2019.